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Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients
Sponsor: Mackay Memorial Hospital
Summary
This is a two-period, two-sequence crossover study in patients receiving maintenance peritoneal dialysis. All participants remain on background darbepoetin alfa therapy throughout the study. The study compares add-on vadadustat plus background darbepoetin alfa with background darbepoetin alfa alone, with each treatment period lasting 8 weeks and separated by a 4-week washout period. Monthly laboratory assessments and dialysis adequacy measurements will be performed to evaluate anemia control, quality of life, inflammation, and dialysis adequacy.
Official title: A Prospective Interventional Study Evaluating the Effects of Vadadustat on Anemia, Quality of Life, and Inflammatory Response in Dialysis Patients and Exploring Predictors of Treatment Response
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-04-15
Completion Date
2026-10-15
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
Vadadustat
Vadadustat administered orally for 8 weeks during the assigned treatment period. In this two-period crossover study, the two treatment periods are separated by a 4-week washout period.